Clinical Study for the Evaluation of the Efficiency of a Device for the Diagnosis of an Internal Rectal Prolapse, a Pelvic Floor Ptosis and for the Determination of an Internal Hernia Into the Douglas Pouch

The recruitment status of this study is unknown because the information has not been verified recently.

The purpose of this study is to determine if the device is supplying sufficient diagnosis results of an internal rectal prolapse, of a pelvic floor ptosis and for the determination of an interal hernia into the Douglas pouch, as well as to determine the technical success of using the device at the patient.

Further study details as provided by Gerhard Pejcl Medizintechnik GmbH:

Primary Outcome Measures:

Determination if the device will be effective for the diagnosis of an internal rectal prolapse, a pelvic floor ptosis and for the determination of an internal hernia into the Douglas pouch. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Determination if the the use of the device will be tolerated by the patient combined with a low level of pain or discomfort. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:

15

Study Start Date:

January 2009

Estimated Study Completion Date:

June 2009

Estimated Primary Completion Date:

May 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Device: Colorectal Stent

Diagnosis of an internal rectal prolapse:

The device will be introduced and placed into the patient via a proctoscopic procedure. After that the doctor can measure and determine the internal rectal prolapse. After the diagnosis results have been received, the device will be removed from the patient via proctoscopic examination. The whole procedure will take approx. 5 minutes.

An additional X-ray examination procedure with the use of contrast media will be made for the determination of a pelvic floor ptosis and for the determination of an internal hernia into the Douglas pouch.

Detailed Description:

Existing diagnosis methods are inadequate, inaccurate, complicated or can only made intraoperatively. The new device should enable a fast and easy examination procedure well tolerated by the patients. The diagnosis results, received with the device, should assist in the accurate selection of patients for operations as well as to avoid any unnecessary operations.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

female patients

patients with ODS-Symptome-Score according Longo of >7

existing results about a perceptible and seeable internal rectal prolapse, pelvic floor ptosis and an internal hernia into the Douglas pouch

patients who correspond to to the ASA 1 - ASA 2 criteria

Exclusion Criteria:

male patients

female patients with inflammable or malign diseases of the urogenital tract as well as of the anorectal area and after rectum operation

female patients with diarrhea

pregnant patients because of the x-ray examination

female patients who get anticoagulants

serious cardiopulmonary disorders

disorders of the blood coagulation

female patients who correspond to the ASA 3 to ASA 4 criteria

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836680